Robocath said today that it won CE Mark approval in the European Union for its R-One cardiovascular-focused robotics system.
The Rouen, France-based company touted the R-One as the first interventional cardiology-focused robotic system to win CE Mark approval. The system is designed to assist in stenting procedures, Robocath said.
The company said that it is planning a new funding round to support commercialization of the device over the next few years.
“The whole Robocath team is proud to have taken this major step forward in our development, which comes just a few days after our first sale of a training robot to the Medical Training & Testing Center in Rouen. Our entry into the market for interventional vascular robotics represents a substantial opportunity for growth. There is the potential for the R-One solution to be installed in more than 3,000 procedure rooms, performing around 1.6 million interventions each year in Europe alone. Building on our CE mark, we expect to finalize a number of strategic distribution partnerships very shortly in high potential geographic areas, with a Europe and Middle-East wide launch expected in 2020,” founder & chairperson Philippe Bencteux said in a press release.
In late 2017, Robocath said that it added about $2 million (€1.7 million) to the more than $5 million it raised earlier that year.
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